SINGLE DOSE GAS INJECTOR

Calibrator, Pressure, Gas

ESCALON MEDICAL TREK

The following data is part of a premarket notification filed by Escalon Medical Trek with the FDA for Single Dose Gas Injector.

Pre-market Notification Details

Device IDK923397
510k NumberK923397
Device Name:SINGLE DOSE GAS INJECTOR
ClassificationCalibrator, Pressure, Gas
Applicant ESCALON MEDICAL TREK 820 SWAN DR. Mukwonago,  WI  53149
ContactRonald Hueneke
CorrespondentRonald Hueneke
ESCALON MEDICAL TREK 820 SWAN DR. Mukwonago,  WI  53149
Product CodeBXX  
CFR Regulation Number868.2620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-10
Decision Date1992-09-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10853480006157 K923397 000

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